An orphan drug is a medicinal agent that has been created exclusively to treat an exceptional medical condition, the ailment itself being denoted to as an orphan disease.

An orphan disease affects a tiny percentage of the populace. Most of the rare illnesses are genetic, and thus are existent throughout the individual's entire life, even if the symptoms do not appear straightaway.

Global Orphan Drugs Market was worth $132.61 billion in 2018 and estimated to be growing at a CAGR of 7.86%, to reach $193.59 billion by 2023.

The growth of the Global Orphan Drugs Market is mainly driven by factors such as extended market exclusivity, rise in cognizance for prompt diagnosis, and improving healthcare infrastructure in developing countries. Moreover, government enticements in the form of endowments, tax credits, and fees waivers are the other major factors boosting the growth of the market. However, factors such as costly procedures & high initial investment, regulatory obstacles and clinical studies hurdles are hindering the growth of the market.

Global Orphan Drugs market is segmented based on Type and Therapeutic. The market for Orphan Drugs, on the basis of Type is segmented into Biological and Non Biological. Non Biological Orphan Drugs lead the global market, on the basis of type with more than 60% of the market share. On the basis of Therapeutic, the global Orphan Drugs market is segmented into Haematology, Neurology, Oncology, and Others. On the basis of Therapeutics, Neurology accounts for almost 40% of the entire global market share.

The market has also been geographically segmented into North America, Europe, Asia-Pacific, Latin America and Middle-East & Africa. U.S accounted for the largest share in the global Orphan Drugs market in 2015, as it spends nearly 20% of its GDP on health. The global market outlook is projected to be positive as more and more governments are adopting policies to encourage this sector, especially in the developing countries.

Presently, the market for orphan drugs represents only about 6% of the complete pharmaceutical market. An extremely conducive environment currently prevails for the growth of the orphan drugs market, thereby encouraging the entry of more companies into the market. The major companies dominating the global Orphan Drugs market are Novartis, GlaxoSmithKline, Roche, Alexion, Sanofi, Bristol Myers Squibb, Pfizer, Vertex, Celgene, and Merck.

1.Introduction

1.1 Market Definition

1.2 Study Deliverables

1.3 Base Currency, Base Year and Forecast Periods

1.4 General Study Assumptions

2. Research Methodology

2.1 Introduction

2.2 Research Phases

2.2.1 Secondary Research

2.2.2 Primary Research

2.2.3 Econometric Modelling

2.2.4 Expert Validation

2.3 Analysis Design

2.4 Study Timeline

3. Overview

3.1 Executive Summary

3.2 Key Inferences

3.3 Epidemology

4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)

4.1 Market Drivers

4.2 Market Restraints

4.3 Key Challenges

4.4 Current Opportunities in the Market

5. Market Segmentation

5.1 Type

5.1.1 Introduction

5.1.2 Biological

5.1.3 Non Biological

5.1.4 Y-o-Y Growth Analysis, By Type

5.1.5 Market Attractiveness Analysis, By Type

5.1.6 Market Share Analysis, By Type

5.2 Therapeutic

5.2.1 Haematology

5.2.2 Neurology

5.2.3 Oncology

5.2.4 Others

5.2.5 Y-o-Y Growth Analysis, By Therapeutic

5.2.6 Market Attractiveness Analysis, By Therapeutic

5.2.7 Market Share Analysis, By Therapeutic

6. Geographical Analysis

6.1 Introduction

6.1.1 Regional Trends

6.1.2 Impact Analysis

6.1.3 Y-o-Y Growth Analysis

6.1.3.1 By Geographical Area

6.1.3.2 By Type

6.1.3.3 By Therapeutic

6.1.4 Market Attractiveness Analysis

6.1.4.1 By Geographical Area

6.1.4.2 By Type

6.1.4.3 By Therapeutic

6.1.5 Market Share Analysis

6.1.5.1 By Geographical Area

6.1.5.2 By Type

6.1.5.3 By Therapeutic

6.2 North America

6.1.1 Introduction

6.1.2 United States

6.1.3 Canada

6.3 Europe

6.2.1 Introduction

6.2.2 U.K

6.2.3 Spain

6.2.4 Germany

6.2.5 Italy

6.2.6 France

6.4 Asia-Pacific

6.3.1 Introduction

6.3.2 China

6.3.3 India

6.3.4 Japan

6.3.5 Australia

6.3.6 South Korea

6.5 Latin America

6.4.1 Introduction

6.4.2 Brazil

6.4.3 Argentina

6.4.4 Mexico

6.4.5 Rest of Latin America

6.6 Middle East & Africa

6.5.1 Introduction

6.5.2 Middle-East

6.5.3 Africa

7.Strategic Analysis

7.1 PESTLE analysis

7.1.1 Political

7.1.2 Economic

7.1.3 Social

7.1.4 Technological

7.1.5 Legal

7.1.6 Environmental

7.2 Porter’s Five analysis

7.2.1 Bargaining Power of Suppliers

7.2.2 Bargaining Power of Consumers

7.2.3 Threat of New Entrants

7.2.4 Threat of Substitute Products and Services

7.2.5 Competitive Rivalry within the Industry

8.Market Leaders' Analysis

8.1 Novartis

8.1.1 Overview

8.1.2 Product Analysis

8.1.3 Financial analysis

8.1.4 Recent Developments

8.1.5 SWOT analysis

8.1.6 Analyst View

8.2 GlaxoSmithKline

8.3 Roche

8.4 Alexion

8.5 Sanofi

8.6 Bristol Myers Squibb

8.7 Pfizer

8.8 Vertex

8.9 Celgene

8.10 Merck

9.Competitive Landscape

9.1 Market share analysis

9.2 Merger and Acquisition Analysis

9.3 Agreements, collaborations and Joint Ventures

9.4 New Product Launches

10.Market Outlook and Investment Opportunities

Appendix

a) List of Tables

b) List of Figures

Global, Regional and country-level analysis and forecasts of the study market; providing Insights on the major countries/regions in which this industry is blooming and to also identify the regions that are still untapped

Segment-level analysis in terms of technology, component, and type along with market size forecasts and estimations to detect key areas of industry growth in detail

Identification of key drivers, restraints, opportunities, and challenges (DROC) in the market and their impact on shifting market dynamics

Study of the effect of exogenous and endogenous factors that affect the global market; which includes broadly demographic, economics, and political, among other macro-environmental factors presented in an extensive PESTLE Analysis

Study the micro environment factors that determine the overall profitability of an Industry, using Porter’s five forces analysis for analysing the level of competition and business strategy development

A comprehensive list of key market players along with their product portfolio, current strategic interests, key financial information, legal issues, SWOT analysis and analyst overview to study and sustain the market environment

Competitive landscape analysis listing out the mergers, acquisitions, collaborations in the field along with new product launches, comparative financial studies and recent developments in the market by the major companies

An executive summary, abridging the entire report in such a way that decision-making personnel can rapidly become acquainted with background information, concise analysis and main conclusions

Expertly devised analyst overview along with Investment opportunities to provide both individuals and organizations a strong financial foothold in the market